This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.

Thursday, May 27, 2010

0. Blogs & News – cGMPs fully effective this June 25th1. FDA Warning Letters as cGMPs become effective2. Micronutrients and Aging3. Natural Clinical Trials Center4. Archived Vitamin Lawyer Webinars5. Vitamin Lawyer connections…-----------------------------------------------------0. Blogs & News – It
is time for you to make sure your Standard Operating Procedures (SOPs)
are in order! The full panoply of current Good Manufacturing (and
Marketing!) Procedures (cGMPs) go into effect for all Dietary Supplement
companies of no matter what size this June. http:// tinyurl
.com/2eu6yjReport from DC: A brief YouTube video… RF on Health Freedom Actions needed now: www .youtube .com/naturalsolutions#p/f/0/UoZ-j0_8v1s--------------------------------Recent
issues of this Memo have covered such topics as Recent Trends in FDA
Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding
“expiration” dates and “best if used by” dates.-----Access to the Vitamin Lawyer Webinars and more:www .NaturalHealthOptions .netDr.
Rima Recommends: new web site with information regarding the Wellness
Center that Dr. Rima E. Laibow MD is opening in Panama at the end of
May: www .DrRima .net – I will be in Panama for the Grand Opening (the
Provincial Governor is cutting the ribbon) for the event. If anyone
wants to travel to Panama for a week and see the Valley of the Moon, a
small party of interested people will be joining me for the trip; please
let me know if you are interested ASAP[Please
note: all URLs in this memo are "broken" with spaces inserted to avoid
the memo being treated as "spam" by certain email service providers.]-----------------------------------------------------

FDA Warning Letters

www .functionalingredientsmag. com/article/NorthSouth-America/fda-inspectors-hone-in-on-gmp-documentation.aspxMay 25, 2010 - FDA inspectors hone in on GMP documentationBy Hank Schultz“As
D-day approaches for the final round of GMP compliance, a preliminary
review of what inspectors have found so far gives small-tier companies
an insight of what to expect.Paper.
Inspectors are going to want to see lots of it, in the form of master
manufacturing plans, standard operating procedures, and records of all
sorts.‘FDA
takes a risk-approached approach. What are the areas of risk right now
for FDA? Let's look at (contamination), and that the products are made
as they are written up to be made, and that there aren't accidental
overages that could potentially raise a red flag,’ said Daniel
Fabricant, scientific affairs vice president for the Natural Products
Association.‘White mounds of paper,’ Fabricant said. ‘If you don't write it down, it didn't happen.’On
June 25, the third and final phase of tougher GMP rules goes into
effect. Those companies with 20 or fewer employees must be in full
compliance with the Food and Drug Administration guidelines…FDA
officials began inspections of larger-sized companies in 2008, and the
number of inspections is increasing every year. The agency completed 12
inspections in fiscal year 2008, 28 in fiscal year 2009, and is doing
many more now…"Quite
honestly, some of the smaller and medium firms are not there yet,’ said
Carl Reynolds, senior advisor in the Division of Dietary Supplement
Programs at FDA's Center for Food Safety and Applied Nutrition….[About SOPs] ‘How do you control that document?’ Caplette said. ‘Is there a revision number? Is there a date to it?’ …‘Whatever
your documentation is, it is finite. It has beginning, a middle and an
end,’ said Michael McGuffin, CEO of the American Herbal Products
Association. ‘Whatever (the documentation requirements are), you can get
there. Once you're there, it's more of a headache than an obstacle.’The
FDA generates documents of its own in the inspection process, including
a 483 letter detailing the shortfalls they found. Companies can expect
to get one of these.‘It's
very, very rare for an inspectors to come into a facility and spent six
to ten days there and say, 'Gee, that was perfect,'’ McGuffin said.‘We
don't see the fact that companies are likely to receive a 483
[deficiency notice] as evidence of failure. The failure would be if you
can't fix what's on the 483,’ he said. …-----------------------------------------------------2. Micronutrients and AgingBruce Ames: Vitamin insufficiency boosting age-related diseaseswww .nutraingredients. com/content/view/print/276676In
an exclusive interview with Stephen Daniells, Professor Bruce Ames from
the University of California, Berkeley explains why his “triage theory”
could have enormous implications for human health.For
many, Professor Ames needs no introduction. In the 1970s, he invented
the Ames Test, a simple and inexpensive assay to check the mutagenicity
of compounds. Since then he has dedicated his research to understanding
the biochemistry of ageing, with a focus on mitochondria, the power
plants of our cells, as well as how micronutrients may prevent disease,
malnutrition, and obesity.So,
when the native New Yorker with over 450 scientific publications tells
you his triage theory is “the most important thing I have ever worked
on”, you sit up and listen.Evolutionary mechanismsTriage
– from the French word trier meaning to sort, separate, or select –
works on the battlefield by military doctors prioritising treatments
depending on the probable survival of the wounded.Prof
Ames’ theory works in much the same way: By appreciating that natural
selection favours short-term survival over the long-term, Prof Ames’
hypothesised that our short-term survival is achieved by prioritising
the allocation of scarce micronutrients. In other words, to stop us
falling over from a lack of iron in the heart, for example, iron is
pulled from non-essential sources.The triage theory is a way of “measuring the insidious damage going on over time”, he said.The
theory was first proposed in 2006 (PNAS, Vol. 103, Pages 17589-94) to
explain why age-related diseases like heart disease, cancer, and
dementia may be unintended consequences of mechanisms developed during
evolution to protect against episodic vitamin/mineral shortages.“If
this hypothesis is correct, micronutrient deficiencies that trigger the
triage response would accelerate cancer, aging, and neural decay but
would leave critical metabolic functions, such as ATP production,
intact,” explained Prof Ames in the Proceedings of the National Academy
of Sciences...While
the finances may be the lacking, scientific support is not. Working
with the “very good” Joyce McCann, PhD, Prof Ames recently applied his
theory to vitamin K. Writing in the American Journal of Clinical
Nutrition (Vol. 90, pp. 889-907), they reported that five of the 16
known vitamin K-dependent proteins are required for coagulation had
critical functions, meaning that animals genetically manipulated to have
inactive forms did not survive.On
the other hand, another five proteins were found to be less critical,
and the animals survived through weaning. However, a lack of these less
critical vitamin K-dependent proteins, inadequate intakes of vitamin K1
from the diet, or vitamin K deficiency were all associated with
age-related conditions, including weaker bones and hardening of the
arteries, which increased the risk of cardiovascular disease. An
increase in the incidence of spontaneous cancer was also observed...Triage theory has cleared every hurdle it has come up against, but that doesn’t surprise Prof Ames.“My triage theory makes sense,” he said. “And it is almost certainly going to be right.”-----------------------------------------------------3. Natural Clinical Trials CenterUpdate: NCT now has a relationship with a National University that is very interestedin
"breaking into" the nutrient clinical study market -- this is an
opportunity to benefit from a university-level study at modest price.
Obviously, the cost will be greater than the cost of a private clinical
study at Dr. Rima's clinic, but, with our special relationship, we can
keep thecosts
down to a reasonable and affordable level. And, of course, you will
have the assurance that the professionals at NCT are keeping close watch
on the protocol and progress of the university study. The Natural
Solutions Center in Volcan, Panama is expected to be opened by the end
of May, so Clinical Trials can begin shortly thereafter. Check out the
Videos and PPT Webinar on the Site! www .NaturalClinicalTrials .org•
New FDA and FTC regulations make your job harder than ever... Recent
changes mean that your company MUST consider Clinic Tests, Studies and
Trials:• To demonstrate product safety• To substantiate product claims• To determine "typical results" for Testimonial Ads• To meet batch testing requirements.• These changes also mean you must not:• Make claims you cannot substantiate• Use Testimonials without disclosing "typical results"•
What can you do to tell your customers that your product is helpful,
effective and important for them to use? Let us show you what we can do
to help you with cost-effective clinical work...Natural
Solutions Wellness Center has established the Natural Clinical Trials
Program - the NCT - to bring our special expertise to natural product
clinical studies, tests and trials.The
NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration
of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions
Staff.--------------------------------------------------------------4. Archived Natural Solutions Vital Connection Webinars with the Vitamin LawyerSetting up a Student Account at VCU is free and relatively easy:www. VitalConnectionUniversity. com[1] Your Ministry, the Law and Alternative PracticesHeld July 9, 2009: This webinar is Archived. – (approximately 2 hours)A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169[2] CAM Advanced Healthcare Practitioner SOPsHeld: May 6, 2009 – This Webinar is Archived.(approximately 2 hours)You can see my short introductory YouTube video at:vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.htmlDirect sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84[3] Bringing New Natural Products to MarketHeld: May 10, 2009 – This Webinar is Archived.(approximately 2 hours)What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102"Your papers must be in order."Are your ingredients "grandfathered" under DSHEA?Have you filed your Structure and Function Claims Notices?Do you have your SOPs (Standard Operating Procedures)Is your web site Site Use Statement up-to-date? Is your Substantiation Notebook ready?Your papers need to be in order before the FDA inspection![4] Sustainable IRAHeld: Saturday June 13, 2009 – This Webinar is Archived.(approximately 2 hours)Sustainable
Retirement Capacity - Protecting the Environment AND Your IRA/401 – At
the Same Time! The Foundation Trustees lead you through an interesting
slide presentation that will help you make important decisions about
where you want to be in the event conditions in the US continue to
deteriorate. Free Webinar ($25 donation suggested). With eBook.Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).----------------------------------------------5. Vitamin Lawyer Connections…Do
you Skype? If so, free Skype.com is one of the easiest ways to contact
me, no matter where I may be. My Skype handle is: vitaminlawyer Our new affiliation site: www .naturalhealthoptions .netDo you have an affiliation program? We’d like to list it. If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …And good advice… for you.“One on One with the Vitamin Lawyer” from Power Pictures Inc.Trailer: www. youtube. com/watch?v=wWPvzpn0YgAwww. powerpicturesinc. net/store.htmlFollow me on Twitter - www. twitter. com/healthfreedomus------------------------------------------------Ralph Fucetola JDwww .NaturalHealthOptions .netwww .vitaminlawyer .comhttp:// vitaminlawyerarchives.blogspot .comhttp:// vitaminlawyerhealthfreedom.blogspot .comwww .globalhealthfreedom. orgIf
you want to unsubscribe to this newsletter, please email me at
ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

Monday, May 10, 2010

0. Blogs & News – Gov’t says: NO RIGHT TO FOOD ACCESS1. Health Freedom of Speech Bills2. IRS – New Nonprofit Reporting – the easy way…3. Natural Clinical Trials Center4. Archived Vitamin Lawyer Webinars5. Vitamin Lawyer connections…-----------------------------------------------------0. Blogs & News – This from a recent Federal Govt Brief, in a raw milk case:[File this under: why we need a Freedom of Health Speech and Conscience Amendment]“There is No Generalized Right to Bodily and Physical Health.“Plaintiffs’
assertion of a “fundamental right to their own bodily and physical
health, which includes what foods they do and do not choose to consume
for themselves and their families” is similarly unavailing because
plaintiffs do not have a fundamental right to obtain any food they
wish…; see also Cowan v. United States, 5 F. Supp. 2d 1235, 1242 (N.D.
Okla.1998) (rejecting a claim that the plaintiff had the fundamental
“right to take whatever treatment he wishes due to his terminal
condition regardless of whether the FDA approves the treatment”).
Finally, even if such a right did exist, it would not render FDA’s
regulations unconstitutional because prohibiting the interstate sale and
distribution of unpasteurized milk [sic] promotes ‘bodily and physical
health.’”--------------------------------Recent
issues of this Memo have covered such topics as Recent Trends in FDA
Warning Letters; the new FTC testimonial Rule and the FDA Rule regarding
“expiration” dates and “best if used by” dates.-----Access to the Vitamin Lawyer Webinars and more:www .NaturalHealthOptions .netDr.
Rima Recommends: new web site with information regarding the Wellness
Center that Dr. Rima E. Laibow MD is opening in Panama at the end of
May: www .DrRima .net – I will be in Panama for the Grand Opening (the
Provincial Governor is cutting the ribbon) for the event. If anyone
wants to travel to Panama for a week and see the Valley of the Moon, a
small party of interested people will be joining me for the trip; please
let me know if you are interested ASAP[Please
note: all URLs in this memo are "broken" with spaces inserted to avoid
the memo being treated as "spam" by certain email service providers.]-----------------------------------------------------1. Health Freedom of Speech BillsFoods
or dietary supplements that may be of benefit for health conditions
are, according to the FDA, unapproved "drugs." Representatives Jason
Chaffetz (R-UT) and Jared Polis (D-CO) the co-chairs of the Dietary
Supplement Caucus, have introduced the Free Speech about Science Act -- H.R. 4913.
This bill would ensure our basic Free Speech in health matter, end
censorship and, according to observers, "enable the natural health
products community to share peer-reviewed scientific findings about
natural health products with the public..."We
have long urged support for Representative Ron Paul’s bills - HR 3394,
the Freedom of Health Speech Act, and HR 3395, the Health Freedom Act.
This new bill joins them to offer the possibility of a real turn-around
in US law; finally supporting the intent of the Dietary Supplement
Health and Education Act of 1994 (DSHEA) that we have broad freedom to
use food for heatlh and fully rejecting the FDA's discredited public
policy of "HARMonizing" especially with international restrictions on
our rights.Action Item: salsa.democracyinaction .org/o/568/p/dia/action/public/?action_KEY=3729.-----------------------------------------------------2. IRS to Begin Revoking Tax Exemptions May 17 for Failure to Filewww .njnonprofits. org/CheckIRSRevocation.html“Thousands
of … nonprofit organizations - including as many as 5,600 public
charities [in NJ] - could be in danger of losing their tax exemptions if
they don't submit required information filings to the IRS by May 17th. …
Under the federal Pension Protection Act of 2006, exempt organizations
that fail to file required Form 990 annual information returns (or, in
the case ofsmall organizations, the Form
990-N e-postcard) for three consecutive years will have their tax
exemptions automatically revoked by the IRS effective on the filing due
date of the third year. The Form 990 or e-postcard is required to be
filed annually by the 15th day of the 5th month following the end of an
organization's fiscal year.

The
first round of revocations will begin May 17, 2010. If tax exemption is
revoked, the only way to reinstate it will be to reapply (at a fee of
as much as $850). You can save your tax-exempt status by filing!If
you are running a nonprofit, consider form 990 N (for nonprofits with
expected gross receipts under $25,000 (I assume in average since
inception). This new rule does not apply to religious bodies which are
exempt from filing form 990.

Here is where form 990 N can be filed on line: www .irs. gov/charities/article/0,,id=169250,00.html

This is what information is required:

1. Employer identification number (EIN).2. Tax year3. Legal name and mailing address4. Any other names the organization uses5. Name and address of a principal officer6. Web site address if the organization has one7. Confirmation that the organization’s annual gross receipts arenormally $25,000 or less 8. If applicable, a statement that the organization has terminated or isterminating (going out of business)-----------------------------------------------------3. Natural Clinical Trials CenterUpdate: NCT now has a relationship with a National University that is very interestedin
"breaking into" the nutrient clinical study market -- this is an
opportunity to benefit from a university-level study at modest price.
Obviously, the cost will be greater than the cost of a private clinical
study at Dr. Rima's clinic, but, with our special relationship, we can
keep thecosts
down to a reasonable and affordable level. And, of course, you will
have the assurance that the professionals at NCT are keeping close watch
on the protocol and progress of the university study. The Natural
Solutions Center in Volcan, Panama is expected to be opened by the end
of May, so Clinical Trials can begin shortly thereafter. Check out the
Videos and PPT Webinar on the Site! www .NaturalClinicalTrials .org•
New FDA and FTC regulations make your job harder than ever... Recent
changes mean that your company MUST consider Clinic Tests, Studies and
Trials:• To demonstrate product safety• To substantiate product claims• To determine "typical results" for Testimonial Ads• To meet batch testing requirements.• These changes also mean you must not:• Make claims you cannot substantiate• Use Testimonials without disclosing "typical results"•
What can you do to tell your customers that your product is helpful,
effective and important for them to use? Let us show you what we can do
to help you with cost-effective clinical work...Natural
Solutions Wellness Center has established the Natural Clinical Trials
Program - the NCT - to bring our special expertise to natural product
clinical studies, tests and trials.The
NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration
of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions
Staff.--------------------------------------------------------------4. Archived Natural Solutions Vital Connection Webinars with the Vitamin LawyerSetting up a Student Account at VCU is free and relatively easy:www. VitalConnectionUniversity. com[1] Your Ministry, the Law and Alternative PracticesHeld July 9, 2009: This webinar is Archived. – (approximately 2 hours)A
PowerPoint discussion with Counsel Ralph Fucetola JD about advanced
health care practices, the ministry and the law. $49.95 - Includes eBook
with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=169[2] CAM Advanced Healthcare Practitioner SOPsHeld: May 6, 2009 – This Webinar is Archived.(approximately 2 hours)You can see my short introductory YouTube video at:vitaminlawyerhealthfreedom.blogspot. com/2009/02/webinar-announcement-ethical-legal.htmlDirect sign-up: http://www.vitalconnectionuniversity.com/moodle/course/view.php?id=84[3] Bringing New Natural Products to MarketHeld: May 10, 2009 – This Webinar is Archived.(approximately 2 hours)What
does it take to bring a new natural product to market? This webinar
will cover the pitfalls and requirements. Especially in the current
market, you need to do everything right to have a success… includes a
useful eBook with forms.Direct sign-up: www. vitalconnectionuniversity. com/moodle/course/view.php?id=102"Your papers must be in order."Are your ingredients "grandfathered" under DSHEA?Have you filed your Structure and Function Claims Notices?Do you have your SOPs (Standard Operating Procedures)Is your web site Site Use Statement up-to-date? Is your Substantiation Notebook ready?Your papers need to be in order before the FDA inspection![4] Sustainable IRAHeld: Saturday June 13, 2009 – This Webinar is Archived.(approximately 2 hours)Sustainable
Retirement Capacity - Protecting the Environment AND Your IRA/401 – At
the Same Time! The Foundation Trustees lead you through an interesting
slide presentation that will help you make important decisions about
where you want to be in the event conditions in the US continue to
deteriorate. Free Webinar ($25 donation suggested). With eBook.Direct IRA link: www. Vitalconnectionuniversity .com/moodle/course/view.php?id=95Each
Webinar includes its own useful eBook of forms and other information
that will help you better organize (includes full powerpoint
presentation text and resources).----------------------------------------------5. Vitamin Lawyer Connections…Do
you Skype? If so, free Skype.com is one of the easiest ways to contact
me, no matter where I may be. My Skype handle is: vitaminlawyer Our new affiliation site: www .naturalhealthoptions .netDo you have an affiliation program? We’d like to list it. If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …And good advice… for you.“One on One with the Vitamin Lawyer” from Power Pictures Inc.Trailer: www. youtube. com/watch?v=wWPvzpn0YgAwww. powerpicturesinc. net/store.htmlFollow me on Twitter - www. twitter. com/healthfreedomus------------------------------------------------Ralph Fucetola JDwww .NaturalHealthOptions .netwww .vitaminlawyer .comhttp:// vitaminlawyerarchives.blogspot .comhttp:// vitaminlawyerhealthfreedom.blogspot .comwww .globalhealthfreedom. orgIf
you want to unsubscribe to this newsletter, please email me at
ralph.fucetola (at) usa.net with “Unsubscribe” in the subject line.

About Me

The Vitamin Conslutancy - www.vitaminconsultancy.com -- I practiced law for 36 years in NJ (1971 - 2006), gaining a reputation as The Vitamin Lawyer, representing people in the Natural Products, Dietary Supplements and CAM (Complementary and Alternative Modalities) fields. Now I provide educational services and I consult with lawyers and other professionals, formulators, manufacturers and purveyors of natural and nutritional products, as well as with CAM enterprises and practitioners.
I started these blogs to comment on health and freedom issues and to provide an archive of information for my clients and associates. This is a private expressive association communication.
I have been a trustee of several NGOs (nongovernmental organizations) including the Natural Solutions Foundation - globalhealthfreedom.org - Institute for Health Research - inhere.org - Sound Health Research Institute - soundhealthresearch.org and LifeSpirit Church - lifespirit.org